Regulatory Affairs Specialist II

6 days ago

Burlington, Massachusetts, United States Fractyl Health Full time
Position Summary

The Regulatory Affairs Specialist II supports the company's regulatory initiatives to meet strategic short- and long-term objectives. This includes assisting with the preparation and submission of regulatory documents, maintaining compliance with applicable regulations, and supporting cross-functional teams during product development and post-market activities. The Specialist works closely with the Principal Regulatory Affairs Specialist and other team members to ensure regulatory requirements are met in a timely and compliant manner.

Primary Responsibilities
  • Support the development and implementation of regulatory submission strategies.
  • Assist with the preparation and maintenance of US regulatory submissions, including IDEs, PMAs, and associated supplements and reports.
  • Help achieve/maintain CE Marking including MDR applications, maintaining technical documentation, and associated compliance activities.
  • Support review of project documentation such as risk management files, test reports, and validations for regulatory completeness.
  • Assess Engineering Change Orders (ECOs) for potential regulatory impact.
  • Collaborate with cross-functional teams to address questions and support responses during submission reviews.
  • Assist in drafting or updating regulatory standard operating procedures (SOPs).
  • Support review of promotional materials for compliance with regulatory requirements.
  • Contribute to clinical trial activities and documentation in line with good clinical practice (GCP) standards.
  • Support internal and external audits and other quality system activities as needed.
  • Perform all duties in compliance with applicable regulations, policies, and procedures, including timely documentation and training completion.
  • Bring a collaborative, solution-oriented attitude to daily work and other responsibilities as assigned.
Education or Certification Requirements
  • Bachelor's degree in Scientific, Engineering, Public Health, or a related field.
  • RAPs Certification preferred.
Professional Work Experience
  • Minimum of 3 years of direct experience in Regulatory Affairs or a related field.
  • Background in medical devices, biologics, or pharmaceutical industries, medical devices preferred.
Qualifications and Skills
  • Strong understanding of FDA and EU regulations and guidance documents.
  • Knowledge of Quality System requirements such as QSR, ISO 13485, GxP.
  • Solid technical writing skills with experience preparing regulatory documentation.
  • Project management skills and the ability to manage timelines within a team environment.
  • Experience with software-based and/or sterile medical devices desirable but not required.
  • Experience with clinical trials desirable but not required.
Other Essentials and Key Success Factors
  • Demonstrated ability to work independently and as part of a cross-functional team.
  • Strong organizational skills with attention to detail.
  • Excellent verbal and written communication skills.
  • Curious, proactive, and eager to learn within a dynamic, fast-paced environment.
  • High degree of professionalism, integrity, and commitment to quality.
Travel

Minimal travel required.

Compensation

This position offers a competitive salary in the range of $115,000 – $150,000 annually, along with a comprehensive benefits package. Actual compensation will be based on relevant experience, education, and market factors.

 

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